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FDA 510(k)

DYNAZYME II Y-GT

K-Number: K771084 · 1977-08-04

ApplicantJ.T. Baker Chemical Co.
Decision Date1977-08-04
Product Code
DecisionSubstantially Equivalent

Device Summary

DYNAZYME II Y-GT is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1977-08-04 under 510(k) number K771084. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAZYME II Y-GT?

DYNAZYME II Y-GT is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K771084.

When did DYNAZYME II Y-GT receive FDA 510(k) clearance?

DYNAZYME II Y-GT received FDA 510(k) clearance on 1977-08-04, under 510(k) number K771084.

Who is the listed applicant for DYNAZYME II Y-GT?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing J.T. Baker Chemical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

View all 54 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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